E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain relief during insertion of an intra uterine device |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10064882 |
E.1.2 | Term | Procedural pain |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the maximum pain intensity experienced by the patient during and within 10 minutes after start of IUD insertion when treated with SHACT in comparison to placebo using a 100 mm VAS scale. |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the pain intensity experienced by the patient after 1 and 2 hours after IUD insertion and after 24, 48 and 72 hours (day 2 – 4) in comparisons between SHACT 4% viscous solution and placebo using a VAS scale
• To evaluate the safety and tolerability of SHACT used during IUD insertion.
• To evaluate the need for rescue medication within the next 4 days after IUD insertion when treated with SHACT compared to placebo.
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Nulliparous women with wish for IUD insertion
• Minimum 18 years of age
•
a) If patient has regular periods, she must be in menstrual cycle day 1-6 at insertion, or pregnancy must be reliably excluded.
b) If patient has no or small irregular bleedings due to hormonal contraception or due to other reasons, the insertion may take place at any convenient day, if pregnancy has been reliably excluded.
• Able to understand Swedish language well enough to be familiar with all study procedures
• Has given written informed consent after verbal and written information
|
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E.4 | Principal exclusion criteria |
• Clinical evidence of or ongoing treatment for active cervical infection
• Positive pregnancy test
• Pelvic inflammatory disease in the last month
• History of uterine conisation
• Known uterine anomaly that contradict IUD insertion
• Copper allergy/Wilson’s disease
• Cervical or uterine cancer
• Known allergy to lidocaine
• Known intolerance to paracetamol (rescue medication)
• Recidivating porphyria
• Any significant morbidity interfering with study drug or procedures according to the assessment of the Principal Investigator
• Taken any analgesics 24 hours prior to IUD insertion
• Previous pregnancy > 13 gestational weeks |
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E.5 End points |
E.5.1 | Primary end point(s) |
Maximum pain intensity experienced by the patient during and within 10 minutes after start of IUD insertion when treated with SHACT in comparison to placebo |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |